NCT06878742 Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
| NCT ID | NCT06878742 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz |
| Condition | Infant, Premature, Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-06-24 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during transitional circulation (first 72 hours from birth).
Eligibility Criteria
Inclusion Criteria: * Born with up to 32(+6) weeks gestation * Presence of hemodynamic insufficiency, defined as SVC flow \<51 ml/kg/min. * Provision of signed and dated informed consent form by father/mother or legally designated representative, which can be given antenatally. Exclusion Criteria: * Neonates considered non-viable, with a clinical decision not to provide life support * Infants with severe congenital hydrops fetalis needing chest or peritoneal drainage before recruitment * Infants already on dobutamine treatment * Infants with congenital malformations likely to affect cardiovascular adaptation (including: congenital diaphragmatic hernia, gastroschisis or congenital heart defects) * Infants with chromosomal anomalies * Lack of parental signed informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06878742 clinical trial?
This trial is open to participants of all sexes, up to 72 Hours, studying Infant, Premature, Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06878742 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06878742 currently recruiting?
Yes, NCT06878742 is actively recruiting participants. Contact the research team at adelina.pellicer@salud.madrid.org for enrollment information.
Where is the NCT06878742 trial being conducted?
This trial is being conducted at Madrid, Spain, Madrid, Spain, Madrid, Spain.
Who is sponsoring the NCT06878742 clinical trial?
NCT06878742 is sponsored by Instituto de Investigación Hospital Universitario La Paz. The trial plans to enroll 30 participants.